Search results for " characterization"
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Techniques for Improving Process Development for Exosome-Derived Therapeutics
This key characterization technology is lacking. I'm optimistic it will be developed in the next few years because there's such a pressing need and flow cytometry is getting closer from an optical sta…
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Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Participants explored strategies for analytical method development, assay validation, product characterization, specification setting, and for establishing relevant manufacturing controls for these hi…
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Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
A decision regarding freeze-thaw parameters must often be made prior to having sufficient amounts of the product available to assess process characterization at manufacturing scale, thereby necessitat…
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Modeling Bioreactor Performance
On a positive note, he points out that as standardization of reactor geometries for single-use systems occurs, the number of reactor geometries that require characterization is decreasing, which is cr…
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Biosimilars: Making the Switch Comes with Challenges
Application dossiers have to give a quality target product profile (QTPP) based on the characterization of multiple batches of the reference product. If necessary, the manufacturing process would be a…
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
FDA, Memorandum: Points to Consider in Characterization of Cell Lines Used to Produce Biologics (Rockville, MD, Jul. 12, 1993).
11. FDA, Memorandum: Points to Consider in the Manufactu…
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Platform Approach Speeds Process Development
In this context, in-depth hardware characterization is crucial for successful scale-up, scale-down, and global site-to-site transfers. Sophisticated tools, such as computational fluid dynamics, enable…
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Ligand-Binding Assays and the Determination of Biosimilarity
In addition, ligand-binding assays enable the characterization of the potency of different biosimilars and provide crucial information on the affinity (dissociation rate constant, KD) and selectivity …
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Setting Standards for Biotech Therapeutics in India
While IPC has a laboratory for characterization of reference standards related to pharmaceutical products, it is in the process of creating a state-of-the-art laboratory for biotech products. At prese…
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Discovering the unknown: How does in silico process development change PD scientists’ work?
This is a huge benefit, for example, for process characterization in late-stage PD. Due to the mechanistic nature of the models, it's even possible to extrapolate from the space investigated during mo…